Indian Drugmakers Must Know Quality-Control Rules, FDA Says

Women walk past the Wockhardt Ltd. manufacturing facility in the Waluj industrial area in Aurangabad, India.

Feb. 19 (Bloomberg) -- Indian companies supplying a quarter
of the medicines used in the U.S. must take responsibility for
the quality-control necessary to export their products, the top
U.S. drug regulator said as it ramps up inspections.

The comments by Margaret Hamburg, the U.S. Food and Drug
Administration commissioner, follow an eight-day trip to India
to meet with pharmaceutical companies on production quality. The
U.S. is increasing scrutiny of generic drugs made in India, and
in the past nine months banned imports from four plants
belonging to Ranbaxy Laboratories Ltd. and Wockhardt Ltd.

The FDA will expand its offices in India, train regulatory
officials in the nation and step up inspections of overseas
plants, Hamburg said in an interview with Bloomberg TV India in
Mumbai yesterday. Until recently, the U.S. wasn’t inspecting
manufacturers in other countries at the same frequency as in the
U.S., the commissioner said. That’s changing, she said.

“If a company wants to do business in the United States,
the responsibility is on them to understand the rules and
requirements,” Hamburg said. “We want to work closely with
companies.”

During her trip, Hamburg agreed to a plan in which Indian
regulators will shadow FDA inspectors on plant visits to observe
the U.S. agency’s practices, Bloomberg News reported Feb. 12.

In the Mumbai interview, she also urged India’s Drug
Controller General and other regulatory authorities in the
country to attend international meetings to discuss drug safety.

‘At the Table’

“Very often when I convene at meetings with my counterpart
regulatory authorities from around the world, India is not
represented at the table,” Hamburg said. “It’s a loss for
them, it’s a loss for us. And I think that the more India is
playing such an important role in the global marketplace, the
more they need to be at the table.”

The FDA is creating an Office of Pharmaceutical Quality to
improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs, Bloomberg News reported Feb. 14. The agency
is also talking directly with the industry to develop data that
may signal which manufacturing plants are straying from
standards and need inspection, said Janet Woodcock, director of
the FDA’s Center for Drug Evaluation and Research.

India’s pharmaceutical companies supply 25 percent of drugs
in the U.S., according to Gaurav Pathak and Shashikiran Rao,
analysts at Standard Chartered Plc in Mumbai.

Share Gains

Ranbaxy rose 4.2 percent to 365.55 rupees. U.S. units of
the drugmaker and Teva Pharmaceutical Industries Ltd. agreed to
settle New York state claims that they colluded to protect each
other’s exclusivity on sales of generic medicines, the state’s
Attorney General Eric Schneiderman said in a statement.

Ranbaxy’s Toansa facility in the north Indian state of
Punjab is the latest Indian facility to face FDA restrictions,
after inspectors last month found drugs were retested to gain
favorable results after initial analyses failed.

In November, Wockhardt was banned from selling some
medicines to the U.S. from its most lucrative factory in India
after the FDA added the plant to its import alert list.

When the agency’s inspectors visited the Wockhardt plant in
July, they found inconsistencies in drug-test results, urine
spilling over open drains, soiled uniforms and mold growing in a
raw-material storage area, according to findings detailed in an
official document obtained by Bloomberg News via a Freedom of
Information Act request.

Facility Inspections

FDA inspections of drug facilities in India rose to 195 in
2012 from 11 in 2002, according to data from the regulator.

“We’re trying to level the playing field,” Hamburg said.
“Wherever a drug is made, if it is sold in the U.S.
marketplace, if American consumers are using it, we need to
assure that they are made according to our standards and
expectations, and have undergone the appropriate review and
inspection.”

The FDA was given the power to collect fees from generic-drug makers in 2012 through the Generic Drug User Fee
Amendments, in part to pay for an increase in inspections of
facilities outside the U.S. The regulator aims to inspect
overseas facilities as frequently as it inspects domestic
manufacturers by 2017.

Hamburg on Feb. 11 met in a closed-door session with 16
drug companies and affiliated groups in New Delhi to discuss
manufacturing quality. Wockhardt and Ranbaxy executives were
among the people who attended the meeting.

U.S. lawmakers are scheduled to hear from doctors,
researchers and patient advocates in a Feb. 26 briefing on
whether substandard generic drugs are leaking into the U.S.
medical system from overseas. Harry Lever, a Cleveland Clinic
cardiologist, plans to say that generic heart-failure drugs made
by India-based companies often don’t work the way they should.